Medtronic is leading the charge on new diabetes devices again, with a first-of-its-kind combo device launched in Europe that brings a continuous glucose monitoring (CGM) sensor and insulin infusion set together into a single device with combined insertion capability!
The company announced its launch of the Minimed Duo on Tuesday, after getting CE Mark approval for European sale early this week.
The magic here is that the Duo merges the insertion needs for both insulin infusion and CGM monitoring into just one spot on the body -- instead of two different sites on your body as has always been required. Note that this is not the full dream of a single cannula -- you'd still have two puncture spots on the skin where the steel catheter and glucose sensor go in -- but you'd only have to push one button on a single, combined inserter to place both your insulin pump and CGM automatically, plus the needles retract so you don't have to see them.
The downside? Since the CGM sensor and infusion set are now connected, you are forced to change them both out at the same time every three days. This of course means that the Medtronic CGM would go from 6-day wear to 3-day wear, which seems like a "a step back" from the current Veo system and Enlite sensor -- although Medtronic disagrees that it's a disadvantage.
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It's a balancing of factors, the company tells us, and customer feedback for years has been clamoring for a single-site device. So Medtronic sees this as a trade-off that will appeal to many people.
A smaller footprint on the body of course means less tape and less skin "real estate" to use and protect. Oh, and the news release says the Duo would include an "improved adhesive pad (that) accommodates movement without compromising adhesion" -- which could be a big advantage in itself!
Unfortunately, there's no set timeline yet for bringing this Minimed Duo to the U.S., but Medtronic's Karrie Hawbaker says the goal is to bring "a more frequent cadence of new technologies to the U.S. market... our current focus is on working with the FDA on a path toward commercialization of the next step toward an Artificial Pancreas system and future generations of the Enlite sensor."
In any case, this is huge, as it could set the precedent for safety and efficacy in an area that's been seriously questioned over the years. But feasibility data presented a year ago at the American Diabetes Association's 73rd Scientific Sessions showed that a combined insertion device is feasible and could "enhance patient compliance and reduce the burden associated with diabetes management."
Indeed, the research behind it could significantly impact the success of other combined, single-site devices being developed by competitors -- including Insulet, which is working with a still-unnamed partner to create an all-in-one OmniPod-CGM device.
Right now, the Minimed Duo is available in mainland Europe and will be expanded to other countries on a "progressive rollout" during the next few months. No details on cost where available yet, but Medtronic says they hope to keep the cost of these combined sensor-infusion sets as close to the existing infusion set and CGM sensor price as possible.
Medtronic is pretty familiar at being "first" when it comes to new diabetes devices. If you recall, Medtronic brought us the first-ever insulin pump in 2003 that wirelessly connected with a glucose meter; an integrated CGM-insulin pump device in 2006; and in 2009 introduced Low Glucose Suspend technology overseas (followed by Low Threshold Suspend here in the States in September 2013).
Aside from this Minimed Duo, most of the attention's been on completing their next-gen system known as the Minimed 640G, a predictive Low Threshold Suspend device able to shut off insulin in advance, whenever it predicts the onset of a low blood sugar. The company says it plans to launch that predictive device by year's end in Europe, and some even believe they may get FDA approval for the U.S. sometime in 2015 (!) And that next-gen pump is rumored to have a completely different design than the "pager-look" we've become accustomed to seeing from Medtronic, so that's exciting too!
At a local diabetes conference I attended recently in Indianapolis, Medtronic's Chief Medical Officer Dr. Fran Kaufman spoke about the company's pipeline and all the coming D-tech we can expect. There was mention of the predictive technology, along with a nice explanation of how all of this is part of the larger Artificial Pancreas goal.
It seems a good time to push the envelope on these kind of diabetes devices given the FDA's new accelerated pathway on medical devices, aimed at quickening the pace of innovation. Hopefully the AP tech, which the FDA has now defined and includes the Minimed 530G system because of its ability to automatically suspend insulin delivery, falls under that umbrella.
Short of bringing the new Minimed Duo and other new products to the States, it's very exciting to see Medtronic rolling out this novel technology that certainly is influencing the rest of the diabetes device industry and brings us more options to help manage our diabetes.
Of course, with this year's ADA Scientific Sessions now less than 10 days away, we can't wait to see and hear what may be showcased under the "yet to be approved" glass displays on the Expo floor in San Francisco... stay tuned for that!
Meanwhile, how would you all feel about the trade-off the Medtronic Duo represents -- is longer CGM sensor life or a single-site device more important?